BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ABC LAPAROSCOPIC HANDPROBE

    K Number: K910889 · Decision Aug 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    13
    Review Days
    178

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    Basic Information

    Device Name
    ABC LAPAROSCOPIC HANDPROBE
    K Number
    K910889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Birtcher Medical Systems, Inc.
    Date Received
    March 4, 1991
    Decision Date
    August 29, 1991
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Birtcher Medical Systems, Inc.

    K Number Device Name
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    K930887 BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)
    K931771 BIRTCHER ENDOSCOPIC CORKSCREW
    K931654 BIRTCHER MAGNETIC RETRIEVER (GS-3100)
    K932987 BIRTCHER LAPAROSCOPE AND ACCESSORIES
    K936114 BIRTCHER PERICARDIAL KNIVES
    K930302 BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
    K933319 BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
    K930496 GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
    Search all 13 clearances from Birtcher Medical Systems, Inc. →